U.S. patent application number 15/998472 was filed with the patent office on 2019-02-21 for intraluminal rotational ultrasound for diagnostic imaging and therapy.
The applicant listed for this patent is Koninklijke Philips N.V.. Invention is credited to Robert Emmett Kearney, Princeton Saroha, Jeremy Stigall.
Application Number | 20190053782 15/998472 |
Document ID | / |
Family ID | 65359982 |
Filed Date | 2019-02-21 |
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United States Patent
Application |
20190053782 |
Kind Code |
A1 |
Stigall; Jeremy ; et
al. |
February 21, 2019 |
Intraluminal Rotational Ultrasound for Diagnostic Imaging and
Therapy
Abstract
An ultrasound system includes an ultrasound device configured to
be positioned within a body lumen of a patient. The ultrasound
device includes a rotatable, flexible elongate drive cable
comprising a proximal portion and a distal portion, a first
ultrasound element disposed at the distal portion of the drive
cable and configured to obtain imaging data of the body lumen while
rotating, and a second ultrasound element disposed at the distal
portion of the drive cable and configured to apply an ultrasound
therapy to the body lumen while rotating. Associated devices,
systems, and methods are also provided.
Inventors: |
Stigall; Jeremy; (Carlsbad,
CA) ; Saroha; Princeton; (Ladera Ranch, CA) ;
Kearney; Robert Emmett; (San Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Koninklijke Philips N.V. |
Eindhoven |
|
NL |
|
|
Family ID: |
65359982 |
Appl. No.: |
15/998472 |
Filed: |
August 15, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62545888 |
Aug 15, 2017 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 8/445 20130101;
A61B 8/0891 20130101; A61B 8/56 20130101; A61B 8/4488 20130101;
A61B 8/0883 20130101; A61N 7/00 20130101; A61N 2007/0082 20130101;
A61N 2007/0043 20130101; A61N 2007/0073 20130101; A61B 8/12
20130101 |
International
Class: |
A61B 8/12 20060101
A61B008/12; A61B 8/00 20060101 A61B008/00 |
Claims
1. An ultrasound system, comprising: an ultrasound device
configured to be positioned within a body lumen of a patient, the
ultrasound device comprising: a rotatable, flexible elongate drive
cable comprising a proximal portion and a distal portion; a first
ultrasound element disposed at the distal portion of the drive
cable and configured to obtain imaging data of the body lumen while
rotating; and a second ultrasound element disposed at the distal
portion of the drive cable and configured to apply an ultrasound
therapy to the body lumen while rotating.
2. The system of claim 1, wherein the first ultrasound element and
the second ultrasound element each comprise a single
transducer.
3. The system of claim 2, wherein the first and second ultrasound
elements comprise the same transducer type.
4. The system of claim 3, wherein the transducer type comprises at
least one of a piezoelectric micromachined ultrasound transducer
(PMUT), a capacitive micromachined ultrasonic transducer (CMUT), a
single crystal, lead zirconate titanate (PZT), or PZT
composite.
5. The system of claim 2, wherein the first and second ultrasound
elements comprise different transducer types.
6. The system of claim 1, wherein a center frequency of the first
ultrasound element is between 10 MHz and 70 Mhz.
7. The system of claim 1, wherein a center frequency of the second
ultrasound element is between 1 kHz and 5 MHz.
8. The system of claim 1, wherein the ultrasound device further
comprises: a housing disposed at the distal portion of the drive
cable, wherein the first ultrasound element and the second
ultrasound element are positioned within the housing.
9. The system of claim 1, wherein the first and second ultrasound
elements are arranged along a longitudinal axis of the drive
cable.
10. The system of claim 1, wherein the first and second ultrasound
elements are adjacent to one another.
11. The system of claim 1, wherein the first and second ultrasound
elements are disposed on opposing sides.
12. The system of claim 1, wherein the ultrasound device further
comprises: a flexible elongate sheath configured to be positioned
with the body lumen, wherein the drive cable is disposed within the
sheath.
13. The system of claim 1, further comprising: a movement device
coupled to the drive cable, wherein movement device is configured
to rotate the drive cable.
14. The system of claim 1, further comprising; a computer in
communication with the first and second ultrasound elements,
wherein the computer is operable to transmit a plurality of control
signals such that the first and second ultrasound elements emit
ultrasound energy at a plurality of different frequencies.
15. An ultrasound method, comprising: obtaining imaging data
representative of a body lumen of a patient using a first
ultrasound element disposed at a distal portion of a rotating
flexible, elongate drive cable positioned within the body lumen;
and applying an ultrasound therapy using a second ultrasound
element disposed at the distal portion of the rotating drive
cable.
16. The method of claim 15, further comprising: evaluating, at a
computer in communication with the first and second ultrasound
elements, the body lumen based on obtained imaging data; and
determining, at the computer, a parameter for the ultrasound
therapy based on the evaluating.
17. The method of claim 15, further comprising: treating the body
lumen using a treatment device.
18. The method of claim 17, wherein the treating comprises
introducing a pharmacological agent within the body lumen.
19. The method of claim 17, further comprising: obtaining further
imaging data of the body lumen using the first ultrasound element
to evaluate the efficacy of treating the body lumen.
20. An ultrasound method, comprising: obtaining imaging data
representative of a body lumen of a patient using a first
ultrasound element disposed at a distal portion of a flexible
elongate member positioned within the body lumen; determining an
ultrasound therapy based on the obtained imaging data; and applying
the determined ultrasound therapy using a second ultrasound element
disposed at the distal portion of the flexible elongate member.
Description
TECHNICAL FIELD
[0001] The present disclosure relates generally to intraluminal
rotational ultrasound device and, in particular, intraluminal
ultrasound device with both imaging and therapeutic functions. For
example, an intraluminal ultrasound device can include both a first
ultrasound transducer for imaging and a second ultrasound
transducer for applying an ultrasound therapy at the distal portion
of a rotating drive cable.
BACKGROUND
[0002] Intravascular ultrasound (IVUS) imaging is widely used in
interventional cardiology as a diagnostic tool for assessing a
diseased vessel, such as an artery, within the human body to
determine the need for treatment, to guide the intervention, and/or
to assess its effectiveness. An IVUS device including one or more
ultrasound transducers is passed into the vessel and guided to the
area to be imaged. The transducers emit ultrasonic energy with
frequencies higher than 10 MHz to create an image of the vessel of
interest. Ultrasonic waves are partially reflected by
discontinuities arising from tissue structures (such as the various
layers of the vessel wall), red blood cells, and other features of
interest. Echoes from the reflected waves are received by the
transducer and passed along to an IVUS imaging system. The imaging
system processes the received ultrasound echoes to produce a
cross-sectional image of the vessel where the device is placed.
[0003] Ultrasound has been used in some drug delivery and
therapeutic applications. Conventionally, due to the different in
operation frequencies between the two, an ultrasound imaging device
and an ultrasound therapeutic device are separate and distinct. In
the case of intravascular imaging and therapy, both the ultrasound
imaging device and the ultrasound therapeutic device have to be
inserted into and withdrawn from the patient's blood vessel at
least once during a procedure workflow. To evaluate the
effectiveness of an ultrasound therapy, the intravascular therapy
device has to be withdrawn from the patient's blood vessel, and the
imaging device has to be re-inserted in to the blood vessel. This
multiplicity of insertion and withdrawal of ultrasound devices not
only is time-consuming but also can increase chances of clinical
complications, such as blood vessel damage.
SUMMARY
[0004] Embodiments of the present disclosure provide an ultrasound
device with combined ultrasound imaging and ultrasound therapy
components. For example, the ultrasound device can be rotational
ultrasound device that is sized and shaped to be positioned within
blood vessels of a patient or any other suitable parts of the
patient body. The ultrasound imaging and ultrasound therapy
components can respectively be individual ultrasound transducers
that are secured adjacent to one another at the distal portion of a
rotating drive cable. The ultrasound imaging transducer (e.g., an
intravascular ultrasound or IVUS transducer) and the ultrasound
therapy transducer operate while the rotating. The systems, devices
and methods described herein advantageously allow for ultrasound
imaging and ultrasound therapy components to be provided on the
same device such that the multiple devices do not need to be
inserted and removed for imaging and therapy. This advantageously
improves the medical workflow for the patient and the
physician.
[0005] According to aspects of the present disclosure, an
ultrasound system is provided. The ultrasound system includes an
ultrasound device configured to be positioned within a body lumen
of a patient, the ultrasound device comprising: a rotatable,
flexible elongate drive cable comprising a proximal portion and a
distal portion; a first ultrasound element disposed at the distal
portion of the drive cable and configured to obtain imaging data of
the body lumen while rotating; and a second ultrasound element
disposed at the distal portion of the drive cable and configured to
apply an ultrasound therapy to the body lumen while rotating.
[0006] In some aspects, the first ultrasound element and the second
ultrasound element each comprise a single transducer. In some
aspects, the first and second ultrasound elements comprise the same
transducer type. In some aspects, the transducer type comprises at
least one of a piezoelectric micromachined ultrasound transducer
(PMUT), a capacitive micromachined ultrasonic transducer (CMUT), a
single crystal, lead zirconate titanate (PZT), or PZT composite. In
some aspects, the first and second ultrasound elements comprise
different transducer types. In some aspects, a center frequency of
the first ultrasound element is between 10 MHz and 70 Mhz. In some
aspects, a center frequency of the second ultrasound element is
between 1 kHz and 5 MHz. In some aspects, the ultrasound device
further comprises: a housing disposed at the distal portion of the
drive cable, wherein the first ultrasound element and the second
ultrasound element are positioned within the housing. In some
aspects, the first and second ultrasound elements are arranged
along a longitudinal axis of the drive cable. In some aspects, the
first and second ultrasound elements are adjacent to one another.
In some aspects, the first and second ultrasound elements are
disposed on opposing sides. In some aspects, the ultrasound device
further comprises: a flexible elongate sheath configured to be
positioned with the body lumen, wherein the drive cable is disposed
within the sheath. In some aspects, the system further comprises a
movement device coupled to the drive cable, wherein movement device
is configured to rotate the drive cable. In some aspects, the
system further comprises a computer in communication with the first
ultrasound element, wherein the computer is operable to transmit a
plurality of control signals such that the first ultrasound element
emits ultrasound energy at a plurality of different frequencies. In
some aspects, the system further comprises a computer in
communication with the second ultrasound element, wherein the
computer is operable to transmit a plurality of control signals
such that the second ultrasound element emits ultrasound energy at
a plurality of different frequencies.
[0007] According to aspects of the present disclosure, an
ultrasound method is provided. The method includes obtaining
imaging data representative of a body lumen of a patient using a
first ultrasound element disposed at a distal portion of a rotating
flexible, elongate drive cable positioned within the body lumen;
and applying an ultrasound therapy using a second ultrasound
element disposed at the distal portion of the rotating drive
cable.
[0008] In some aspects, the method further comprises: evaluating,
at a computer in communication with the first and second ultrasound
elements, the body lumen based on obtained imaging data; and
determining, at the computer, a parameter for the ultrasound
therapy based on the evaluating. In some aspects, the method
further comprises treating the body lumen using a treatment device.
In some aspects, the treating comprises introducing a
pharmacological agent within the body lumen. In some aspects, the
method further comprises: obtaining further imaging data of the
body lumen using the first ultrasound element to evaluate the
efficacy of treating the body lumen.
[0009] According to aspects of the present disclosure, an
ultrasound method is provided. The method includes obtaining
imaging data representative of a body lumen of a patient using a
first ultrasound element disposed at a distal portion of a flexible
elongate member positioned within the body lumen; determining an
ultrasound therapy based on the obtained imaging data; and applying
the determined ultrasound therapy using a second ultrasound element
disposed at the distal portion of the flexible elongate member.
[0010] Additional aspects, features, and advantages of the present
disclosure will become apparent from the following detailed
description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Illustrative embodiments of the present disclosure will be
described with reference to the accompanying drawings, of
which:
[0012] FIG. 1 is diagrammatic schematic view of an ultrasound
system according to some embodiments of the present disclosure.
[0013] FIG. 2 is diagrammatic schematic view of an ultrasound
system according to some embodiments of the present disclosure.
[0014] FIG. 3 is diagrammatic schematic view of a rotational
ultrasound device according to some embodiments of the present
disclosure.
[0015] FIG. 4 is diagrammatic view of a rotational ultrasound
device in situ within anatomy of a patient according to some
embodiments of the present disclosure.
[0016] FIG. 5 is diagrammatic perspective view of a distal portion
of a rotational ultrasound device in according to some embodiments
of the present disclosure.
[0017] FIG. 6 is diagrammatic side view of a distal portion of a
rotational ultrasound device in according to some embodiments of
the present disclosure.
[0018] FIG. 7 is a flow diagram of an ultrasound imaging and
ultrasound therapy method according to embodiments of the present
disclosure.
DETAILED DESCRIPTION
[0019] For the purposes of promoting an understanding of the
principles of the present disclosure, reference will now be made to
the embodiments illustrated in the drawings, and specific language
will be used to describe the same. It is nevertheless understood
that no limitation to the scope of the disclosure is intended. Any
alterations and further modifications to the described devices,
systems, and methods, and any further application of the principles
of the present disclosure are fully contemplated and included
within the present disclosure as would normally occur to one
skilled in the art to which the disclosure relates. For example, it
is fully contemplated that the features, components, and/or steps
described with respect to one embodiment may be combined with the
features, components, and/or steps described with respect to other
embodiments of the present disclosure. For the sake of brevity,
however, the numerous iterations of these combinations will not be
described separately.
[0020] FIG. 1 is a diagrammatic schematic view of an ultrasound
system 100 according to some embodiments of the present disclosure.
The system 100 can include an ultrasound device 110, a patient
interface module (PIM) 150, an ultrasound processing system 160,
and/or a monitor 170. The ultrasound device 110 is structurally
arranged (e.g., sized and/or shaped) to be positioned within
anatomy 102 of a patient. The ultrasound device 110 obtains
ultrasound imaging data from within the anatomy 102 and applies
ultrasound therapy to the anatomy 102. The ultrasound processing
system 160 can control the acquisition of ultrasound imaging data
and/or the application of ultrasound therapy, and generates an
image of the anatomy 102 (using the ultrasound imaging data
received via the PIM 150) that is displayed on the monitor 170.
[0021] Generally, the ultrasound device 110 can be a catheter, a
guide catheter, or a guide wire. The ultrasound device 110 includes
a flexible elongate member 116. As used herein, "elongate member"
or "flexible elongate member" includes at least any thin, long,
flexible structure structurally arranged (e.g., sized and/or
shaped) to be positioned within a lumen 104 of the anatomy 102. For
example, a distal portion 114 of the flexible elongate member 116
is positioned within the lumen 104, while a proximal portion 112 of
the flexible elongate member 116 is positioned outside of the body
of the patient. The flexible elongate member 116 can include a
longitudinal axis LA. In some instances, the longitudinal axis LA
can be a central longitudinal axis of the flexible elongate member
116. In some embodiments, the flexible elongate member 116 can
include one or more polymer/plastic layers formed of various grades
of nylon, Pebax, polymer composites, polyimides, and/or Teflon. In
some embodiments, the flexible elongate member 116 can include one
or more layers of braided metallic and/or polymer strands. The
braided layer(s) can be tightly or loosely braided in any suitable
configuration, including any suitable per in count (pic). In some
embodiments, the flexible elongate member 116 can include one or
more metallic and/or polymer coils. All or a portion of the
flexible elongate member 116 may have any suitable geometric
cross-sectional profile (e.g., circular, oval, rectangular, square,
elliptical, etc.) or non-geometric cross-sectional profile. For
example, the flexible elongate member 116 can have a generally
cylindrical profile with a circular cross-sectional profile that
defines an outer diameter of the flexible elongate member 116. For
example, the outer diameter of the flexible elongate member 116 can
be any suitable value for positioning within the anatomy 102,
including between approximately 1 Fr and approximately 15 Fr,
including values such as 3.5 Fr, 5 Fr, 7 Fr, 8.2 Fr, 9 Fr, and/or
other suitable values both larger and smaller.
[0022] The ultrasound device 110 may or may not include one or more
lumens extending along all or a portion of the length of the
flexible elongate member 116. The lumen of the ultrasound device
110 can be structurally arranged (e.g., sized and/or shaped) to
receive and/or guide one or more other diagnostic and/or
therapeutic instruments. If the ultrasound device 110 includes
lumen(s), the lumen(s) may be centered or offset with respect to
the cross-sectional profile of the device 110. In the illustrated
embodiment, the ultrasound device 110 is a catheter and includes a
lumen at the distal portion 114 of the flexible elongate member
116. A guide wire 140 extends through the lumen of the catheter 110
between an entry/exit port 142 and an exit/entry port at a distal
end 118 of the flexible elongate member 116. Generally, the guide
wire 140 is a thin, long, flexible structure that is structurally
arranged (e.g., sized and/or shaped) to be disposed within the
lumen 104 of the anatomy 102. During a diagnostic and/or
therapeutic procedure, a medical professional typically first
inserts the guide wire 140 into the lumen 104 of the anatomy 102
and moves the guide wire 140 to a desired location within the
anatomy 102, such as adjacent to an occlusion 106. The guide wire
140 facilitates introduction and positioning of one or more other
diagnostic and/or therapeutic instruments, including the ultrasound
device 110, at the desired location within the anatomy 102. For
example, the ultrasound device 110 moves through the lumen 104 of
the anatomy 102 along the guide wire 140. In some embodiments, the
lumen of the ultrasound device 110 can extend along the entire
length of the flexible elongate member 116. In the illustrated
embodiment, the exit/entry port 142 is positioned proximally of
components 120, 130, and 145 of the ultrasound device 110. In some
embodiments, the exit/entry port 142, the exit/entry port at the
distal end 118, and/or the lumen of the ultrasound device 110 is
positioned distally of the components 120, 130, and 145. In some
embodiments, the ultrasound device 110 is not used with a guide
wire, and the exit/entry port 142 can be omitted from the
ultrasound device 110.
[0023] The anatomy 102 may represent any fluid-filled or surrounded
structures, both natural and man-made. For example, the anatomy 102
can be within the body of a patient. Fluid can flow through the
lumen 104 of the anatomy 102. In some instances, the ultrasound
device 110 can be referenced as an intraluminal device. The anatomy
102 can be a vessel, such as a blood vessel, in which blood flows
through the lumen 104. In some instances, the ultrasound device 110
can be referenced as an intravascular device. In various
embodiments, the blood vessel is an artery or a vein of a patient's
vascular system, including cardiac vasculature, peripheral
vasculature, neural vasculature, renal vasculature, and/or any
other suitable anatomy/lumen inside the body. The anatomy 102 can
be tortuous in some instances. For example, the device 110 may be
used to examine any number of anatomical locations and tissue
types, including without limitation, organs including the liver,
heart, kidneys, gall bladder, pancreas, lungs, esophagus; ducts;
intestines; nervous system structures including the brain, dural
sac, spinal cord and peripheral nerves; the urinary tract; as well
as valves within the blood, chambers or other parts of the heart,
and/or other systems of the body. In addition to natural
structures, the device 110 may be used to examine man-made
structures such as, but without limitation, heart valves, stents,
shunts, filters and other devices.
[0024] The occlusion 106 of the anatomy 102 is generally
representative of any blockage or other structural arrangement that
results in a restriction to the flow of fluid through the lumen
104, for example, in a manner that is deleterious to the health of
the patient. For example, the occlusion 106 narrows the lumen 104
such that the cross-sectional area of the lumen 104 and/or the
available space for fluid to flow through the lumen 104 is
decreased. Where the anatomy 102 is a blood vessel, the occlusion
106 may be a result of plaque buildup, including without limitation
plaque components such as fibrous, fibro-lipidic (fibro fatty),
necrotic core, calcified (dense calcium), blood, fresh thrombus,
and/or mature thrombus. In some instances, the occlusion 106 can be
referenced as thrombus, a stenosis, and/or a lesion. Generally, the
composition of the occlusion 106 will depend on the type of anatomy
being evaluated. Healthier portions of the anatomy 102 may have a
uniform or symmetrical profile (e.g., a cylindrical profile with a
circular cross-sectional profile). The occlusion 106 may not have a
uniform or symmetrical profile. Accordingly, diseased portions of
the anatomy 102, with the occlusion 106, will have a non-symmetric
and/or otherwise irregular profile. While the anatomy 102 is
illustrated in FIG. 1 as having a single occlusion 106, it is
understood that the devices, systems, and methods described herein
have similar application for anatomy having multiple
occlusions.
[0025] The ultrasound device 110 includes ultrasound structures 120
and 130 at the distal portion 114 of the flexible elongate member
116. The structures 120 and 130 are configured to emit ultrasonic
energy into the anatomy 102 while the device 110 is positioned
within the lumen 104. In some embodiments, the two ultrasound
structures 120 and 130 are distinct. In other embodiments, the two
structures 120 and 130 are the same ultrasound component or part of
the same ultrasound component. One of the structures 120, 130 is
configured for diagnostic use, while the other of the structures
120, 130 is configured for therapeutic use. For example, the
structures 120, 130 can emit different frequencies of ultrasonic
energy into the anatomy 102 depending on whether the ultrasonic
energy is being used for diagnosis, such as imaging, and/or
treatment.
[0026] In some embodiments, the structures 120 and/or 130 include
ultrasound transducer(s). For example, the ultrasound structures
120 and/or 130 can be configured to generate and emit ultrasound
energy into the anatomy 102 in response to being activated by an
electrical signal. In some embodiments, the structures 120 and/or
130 include a single ultrasound transducer. In some embodiments,
the structures 120 and/or 130 include an ultrasound transducer
array including more than one ultrasound transducer. For example,
an ultrasound transducer array can include any suitable number of
individual transducers between 2 transducers and 1000 transducers,
including values such as 2 transducers, 4 transducers, 36
transducers, 64 transducers, 128 transducers, 500 transducers, 812
transducers, and/or other values both larger and smaller. The
ultrasound transducer array 120 and/or 130 can be any suitable
configuration, such as phased array including a planar array, a
curved array, a circumferential array, an annular array, etc. For
example, the ultrasound transducer array 120 and/or 130 can be a
one-dimensional array or a two-dimensional array in some instances.
In some instances, the structures 120 and/or 130 can be a
rotational ultrasound device. The active area of the ultrasound
structures 120 and/or 130 can include one or more transducer
materials and/or one or more segments of ultrasound elements (e.g.,
one or more rows, one or more columns, and/or one or more
orientations) that can be uniformly or independently controlled and
activated. The active area of the ultrasound structures 120 and/or
130 can be patterned or structured in various basic or complex
geometries. The structures 120 and/or 130 can be disposed in a
side-looking orientation (e.g., ultrasonic energy emitted
perpendicular and/or orthogonal to the longitudinal axis LA) and/or
a forward-looking looking orientation (e.g., ultrasonic energy
emitted parallel to and/or along the longitudinal axis LA). In some
instances, the structures 120 and/or 130 is structurally arranged
to emit and/or receive ultrasonic energy at an oblique angle
relative to the longitudinal axis LA, in a proximal or distal
direction. In some embodiments, ultrasonic energy emission can be
electronically steered by selective triggering of one or more
transducer elements of the array 120 and/or 130.
[0027] The ultrasound transducer(s) of the structures 120 and/or
130 can be a piezoelectric micromachined ultrasound transducer
(PMUT), capacitive micromachined ultrasonic transducer (CMUT),
single crystal, lead zirconate titanate (PZT), PZT composite, other
suitable transducer type, and/or combinations thereof. Depending on
the transducer material, the manufacturing process for ultrasound
transducer(s) can include dicing, kerfing, grinding, sputtering,
wafer technologies (e.g., SMA, sacrificial layer deposition), other
suitable processes, and/or combinations thereof.
[0028] In some embodiments, the structure 120 is configured to
obtain ultrasound imaging data associated with the anatomy 102,
such as the occlusion 106. The ultrasound imaging data obtained by
the structure 120 can be used by a medical professional to diagnose
the patient, including evaluating the occlusion 106 of the anatomy
102. For imaging, the structure 120 can be configured to both emit
ultrasonic energy into the lumen 104 and/or the anatomy 102, and to
receive reflected ultrasound echoes representative of fluid and/or
tissue of lumen 104 and/or the anatomy 102. As described herein,
the structure 120 can be an ultrasound imaging element, such as an
ultrasound transducer and/or an ultrasound transducer array. For
example, the ultrasound imaging element 120 generates and emits
ultrasound energy into the anatomy 102 in response to transmission
of an electrical signal to the structure 120. For imaging, the
ultrasound imaging element 120 generates and transmits an
electrical signal representative of the received reflected
ultrasound echoes from the anatomy 102 (e.g., to the PIM 150 and/or
computer 160). In various embodiments, the structure 120 can obtain
imaging data associated with intravascular ultrasound (IVUS)
imaging, forward looking intravascular ultrasound (FL-IVUS)
imaging, intravascular photoacoustic (IVPA) imaging, intracardiac
echocardiography (ICE), transesophageal echocardiography (TEE),
and/or other suitable imaging modalities.
[0029] For diagnosis and/or imaging, the center frequency of the
ultrasound structure 120 can be between 10 MHz and 70 MHz, for
example, including values such as 10 MHz, 20 MHz, 40 MHz, 45 MHz,
60 MHz, and/or other suitable values both larger and smaller. For
example, lower frequencies (e.g., 10 MHz, 20 MHz) can
advantageously penetrate further into the anatomy 102, such that
more of the anatomy 102 is visible in the ultrasound images. Higher
frequencies (e.g., 45 MHz, 60 MHz) can be better suited to generate
more detailed ultrasound images of the anatomy 102 and/or fluid
within the lumen 104. In some embodiments, the frequency of the
ultrasound structure 120 is tunable. For imaging, in some
instances, the ultrasound structure 120 can be tuned to receive
wavelengths associated with the center frequency and/or one or more
harmonics of the center frequency. In some instances, the frequency
of the emitted ultrasonic energy can be modified by the voltage of
the applied electrical signal and/or the application of a biasing
voltage to the ultrasound structure 120.
[0030] In some embodiments, the structure 130 is configured to
apply an ultrasound therapy to the anatomy 102, such as the
occlusion 106. For example, the structure 130 emits sound waves
that damage the structure of the occlusion 106. In that regard, the
device 110 and/or the structure 130 can be referenced as a
lithotripsy device. The ultrasonic energy emitted by the structure
130 can create micro fractures in the calcium blockage 106. For
example, the structure 130 can deliver ultrasonic energy in a
targeted manner to cause cavitation (e.g., wave force cavitation,
thermal cavitation, etc.) of the occlusion 106. Delivery of
ultrasound therapy by the structure 130 advantageously facilitates
thrombus dilution and/or vessel preparation. For example,
ultrasound therapy can be applied prior to delivery of a
pharmacological agent to the anatomy 102. The pharmacological agent
can be a thrombolytic agent, a fibrinolytic agent, plasmin,
plasmid, tissue plasminogen activator, urokinase, streptokinase,
collagenace, hepranoid, anti-thrombin drug, any other suitable
drug, and/or combinations thereof. As described herein,
Pharmacological uptake can be advantageously improved as a result
of the degradation of the occlusion 106 by the ultrasonic energy.
By compromising the structure of the occlusion 106, additional
surface area is available for the pharmacological agent to contact
and/or penetrate the anatomy 102. Accordingly, the efficacy of the
treatment and the health of the patient is improved.
[0031] In some embodiments, the structure 130 is an ultrasound
element, such as an ultrasound transducer and/or ultrasound
transducer array. For example, the ultrasound imaging element 130
can be configured to generate and emit ultrasound energy into the
anatomy 102 in response to transmission of an electrical signal to
the structure 130. Unlike the structure 120, which is used of
ultrasound imaging, the structure 130 need not be configured to
receive ultrasonic echoes reflected the anatomy 102 and generate a
representative electrical signal. For example, in some embodiments,
the structure 130 is not an ultrasound element that generates
ultrasound energy. Rather, the structure 130 can be an intermediate
component that is configured to deliver ultrasound energy generated
an ultrasound component separate from the device 110 (e.g., an
external ultrasound transducer positioned outside of the body of
the patient). For ultrasound therapy, the center frequency of the
ultrasound structure 130 can be between 1 kHz and 5 MHz, for
example, including values such as 50 kHz, 500 kHz, 1 MHz, 3 MHz,
and/or other suitable values both larger and smaller. In some
embodiments, the frequency of the ultrasound structure 130 is
tunable. For example, the frequency of the emitted ultrasonic
energy can be modified by the voltage of the applied electrical
signal and/or the application of a biasing voltage to the
ultrasound structure 130.
[0032] In some embodiments, such as when the structures 120 and 130
both include ultrasound transducers, the structures 120 and 130 can
be configured to generate and to emit ultrasound energy, and to
generate electrical signals representative of the received
ultrasound echoes. One of the structures 120, 130 can be operated
in diagnostic and/or imaging mode (generates and emits ultrasound
energy, and generates electrical signals representative of the
received ultrasound echoes), while the other of the structures 120,
130 is operated in therapeutic mode (generates and/or emits
ultrasound energy).
[0033] In some embodiments, the ultrasound device 110 includes a
treatment component 145. For example, the treatment component 145
can include a balloon, a stent, a needle, an ablation electrode,
mechanical cutting component, a rotational cutting device, an
aspiration device, and/or other suitable devices. The treatment
component 145 can be a targeted drug delivery device, a drug coated
balloon, a drug coated stent, and/or other suitable device
configured to deliver a pharmacological agent to the anatomy 102,
such as the occlusion 106. For example, the pharmacological agent
can be delivered to the anatomy 102 by the treatment component 145
after the ultrasound therapy is applied to the anatomy 102 by the
ultrasound structure 130. In other embodiments, the ultrasound
device 110 omits the treatment component 145.
[0034] Generally, the components 120, 130, and/or 145 are
positioned at the distal portion of the flexible elongate member
116. The relative positioning of the components 120, 130, and/or
145 can vary in different embodiments. In the illustrated
embodiment, the diagnostic and/or imaging ultrasound structure 120
is positioned proximally of the therapeutic ultrasound structure
130. In other embodiments, the therapeutic ultrasound structure 130
is positioned proximally of the diagnostic and/or imaging
ultrasound structure 120. In embodiments which include the
treatment component 145, the treatment component 145 can be
positioned proximally of the ultrasound structures 120 and/or 130,
distally of the ultrasound structures 120 and/or 130, or between
the ultrasound structures 120 and/or 130.
[0035] The ultrasound structures 120 and/or 130 can include one or
more electrical conductors extending along the length from the
flexible elongate member 116. The electrical conductor(s) are in
communication with the ultrasound structures 120, 130 at the distal
portion 114, and an interface 156 at the proximal portion 112. The
electrical conductors carry electrical signals between the
ultrasound processing system 160 and the ultrasound structures 120,
130. For example, activation and/or control signals can be
transmitted from the computer 160 to the ultrasound structures 120,
130 via the electrical conductors. Electrical signals
representative of the reflected ultrasound echoes can be
transmitted from the ultrasound structures 120 and/or 130 to the
computer 160 via the electrical conductors. In some embodiments,
the same electrical conductors can be used for communication
between the computer 160 and the ultrasound structures 120 and/or
130. In other embodiments, different electrical conductors of the
device 110 can be used for communication between the computer 160
and the ultrasound structure 120, and between the computer 160 and
the ultrasound structure 130.
[0036] The ultrasound device 110 includes an interface 156 at the
proximal portion 112 of the flexible elongate member 116. In some
embodiments, the interface 156 can include a handle. For example,
handle can include one or more actuation mechanisms to control
movement of the device 110, such as deflection of the distal
portion 114. In some embodiments, the interface 156 can include a
telescoping mechanism that allows for pullback of the device 110
through the lumen. In some embodiments, the interface 156 can
include a rotation mechanism to rotate one or more components of
the device 110 (e.g., the flexible elongate member 116, the
ultrasound structures 120, 130). In some embodiments, the interface
156 includes a user interface component (e.g., one or more buttons,
a switch, etc.) for a medical professional to selectively activate
the ultrasound structure 120 for imaging or the ultrasound
structure 130 for therapy. In other embodiments, a user interface
component of the PIM 150, the computer 160 and/or the monitor 170
allows a medical profession to selectively activate the ultrasound
structure 120 for imaging or the ultrasound structure 130 for
therapy. A conduit including, e.g., electrical conductors, extends
between the interface 156 and the connector 108. The connector 108
can be configured to mechanically and/or electrically couple the
device 110 to the PIM 150.
[0037] The ultrasound processing system 160, the PIM 150, and/or
the intravascular device 110 (e.g., the interface 156, the
ultrasound structures 120 and/or 130, etc.) can include one or more
controllers. The controllers can be integrated circuits, such as
application specific integrated circuits (ASIC), in some
embodiments. The controllers can be configured to select the
particular transducer element(s) to be used for transmit and/or
receive, to provide the transmit trigger signals to activate the
transmitter circuitry to generate an electrical pulse to excite the
selected transducer element(s), and/or to accept amplified echo
signals received from the selected transducer element(s) via
amplifiers of controllers. Multiple ASIC configurations with
various numbers of master circuits and slave circuits can be used
to create a single ultrasound wave or multi-firing ultrasound wave
device.
[0038] In some embodiments, the PIM 150 performs preliminary
processing of the ultrasound echo data prior to relaying the data
to the computer or console 160. In examples of such embodiments,
the PIM 150 performs amplification, filtering, and/or aggregating
of the data. In an embodiment, the PIM 150 also supplies high- and
low-voltage DC power to support operation of the device 110
including circuitry associated with the ultrasound structures 120
and/or 130. The PIM 150 can be an isolation device as, in various
surgical settings, patient safety requirements mandate physical and
electrical isolation of the patient from one or more high voltage
components.
[0039] The ultrasound processing system 160 receives imaging data
(e.g., electrical signals representative of the ultrasound echo
data) from the ultrasound structure 120 by way of the PIM 150. The
computer 160 can include processing circuit, such as processor
and/or memory. The ultrasound processing system 160 processes the
data to reconstruct an image of the anatomy. The computer 160
outputs image data such that an image of the anatomy 102, such as a
cross-sectional IVUS image of a vessel, is displayed on the monitor
170. The computer 160 and/or the monitor 170 can include one or
more user interface elements (e.g., touchscreen, keyboard, mouse,
virtual buttons on a graphical user interface, physical buttons,
etc.) to allow a medical professional to control the device 110,
including one or more parameters of the ultrasound structures 120,
130.
[0040] FIG. 2 is a diagrammatic, schematic view of the ultrasound
system 100, according to an embodiment of the present disclosure.
FIG. 3 is a diagrammatic, partial cutaway perspective view of the
catheter 110 according to an embodiment of the present disclosure.
FIG. 4 is a diagrammatic view of the catheter 110 in situ within
the vessel 102.
[0041] Referring in particular to FIG. 2, in some embodiments of
the present disclosure, the ultrasound system 100 is a rotational
IVUS imaging and therapeutic ultrasound system. The rotational
ultrasound system 100 can include the rotational catheter 110, the
console or processing system 160, and the monitor 170. As discussed
in greater detail herein, the catheter 110 includes the ultrasound
transducer 120 for imaging and the ultrasound transducer 130 for
therapy. The catheter 110 can also include circuitry associated
with the transducers 120 and/or 130 mounted near the distal tip of
the catheter, an electrical cable with one, two, three, four or
more conductors, and the appropriate connector at the proximal
portion 112 to support mechanical and/or electrical interconnection
at a rotational interface. The body of the rotational catheter 110
can be referenced as the flexible elongate member 116. The distal
portion 114 of the catheter 110 is positioned within the anatomy
102 of the patient. The proximal portion 112 of the catheter 110 is
mechanically and/or electrically coupled to a movement device 180
of the system 100. The movement device includes one or more motors,
associated circuitry, and/or other suitable components structurally
arranged to impart rotational and/or longitudinal movement to one
or more components of the catheter 110, such as a drive cable 210.
The movement device 180 can be referenced as a pullback device
and/or a sled in some instances.
[0042] In some embodiments, the movement device 180 and the PIM 150
can be combined in single device. In other embodiments, the system
100 includes a PIM 150 distinct from the movement device 180. The
PIM 150 generates the required sequence of transmit trigger signals
and control waveforms to regulate the operation of the circuitry
associated with the transducers 120 and 130, and processes the
amplified echo signals received over the conductors of the
electrical cable. The PIM 150 also supplies the high- and
low-voltage DC power supply to support operation of the transducers
120, 130. In that regard, the PIM 150 is structurally arranged to
DC supply voltages to the circuitry of the catheter 110 across a
rotational interface, using slip rings and/or the implementation of
the active spinner technology described in U.S. Pat. No. 8,403,856,
which is hereby incorporated by reference in its entirety. In some
embodiments, the PIM 150 supplies AC voltage to the transducers
120, 130 using, e.g., a rotary transformer.
[0043] FIGS. 3 and 4 illustrate additional detail regarding the
structure of the rotational ultrasound catheter 110. FIG. 4 also
shows the catheter 110 in situ in the anatomy 102. In some
respects, the catheter 110 is similar to rotational IVUS catheters
such as the Revolution.RTM. catheter available from Volcano
Corporation and described in U.S. Pat. No. 8,104,479, or those
disclosed in U.S. Pat. Nos. 5,243,988 and 5,546,948, each of which
is hereby incorporated by reference in its entirety. In that
regard, the rotational catheter 110 includes an imaging core 210
and an outer catheter/sheath assembly 212. The imaging core 210
includes a flexible drive cable or shaft that is terminated at the
proximal end of the proximal portion 112 by a rotational interface
214 providing electrical and mechanical coupling to the PIM 150.
The imaging core 210 can also include one, two, three, four, or
more electrical conductors in communication with the transducers
120, 130. The distal portion 114 of the flexible drive shaft of the
imaging core 210 is mechanically coupled to a proximal portion of a
transducer housing 216 containing the transducers 120 and 130, and
associated circuitry, as described in more detail herein.
[0044] The catheter/sheath assembly 212 includes a hub 218 that
supports the rotational interface 214 and provides a bearing
surface and a fluid seal between the rotating and non-rotating
elements of the catheter 110. The hub 218 includes a luer lock
flush port 220 through which saline is injected to flush out the
air within the sheath 212 and fill the inner lumen of the sheath
212 with an ultrasound-compatible fluid at the time of use of the
catheter 110. The saline or other similar flush is typically
required since air does not readily conduct ultrasound. Saline also
provides a biocompatible lubricant for the rotating drive cable of
the imaging core 210. The hub 218 is coupled to a telescope 222
that includes nested tubular elements and a sliding fluid seal that
permit the catheter/sheath assembly 212 to be lengthened or
shortened to facilitate axial or longitudinal movement of the
transducer housing within an acoustically transparent window 224 of
the distal portion of the catheter 110. In some embodiments, the
window 224 is composed of thin-walled plastic tubing fabricated
from material(s) that readily conduct ultrasound waves between the
transducer and the vessel tissue with minimal attenuation,
reflection, or refraction. A proximal shaft 226 of the
catheter/sheath assembly 212 bridges the segment between the
telescope 222 and the window 224, and is composed of a material or
composite that provides a lubricious internal lumen and optimum
stiffness, but without the need to conduct ultrasound. The
guidewire entry/exit port 142 is provided at the distal portion of
catheter 110 in the illustrated embodiment.
[0045] The movement device 180 rotates the drive cable of the
imaging core 210 (e.g., in a clockwise or counter-clockwise
direction 230) inside the polymer/plastic sheath 212 inserted into
lumen 104 of the anatomy 102. Rotation of the drive cable 210
causes corresponding rotation of the housing 216, which is
mechanically coupled to the drive cable. The transducers 120 and
130 are fixedly secured to the housing 216, and correspondingly
rotate with the drive cable 210. The transducer elements 120, 130
are oriented such that the respective ultrasound beams 124, 134
propagate generally perpendicular to the longitudinal axis LA of
the catheter 110. The fluid-filled sheath 212 protects the tissue
of the anatomy from the spinning transducers 120, 130 and the
driveshaft 210 while permitting ultrasound signals to freely
propagate. As the driveshaft rotates (e.g., at 30 revolutions per
second), the transducers 120, 130 are selectively and/or
periodically excited with a high voltage pulse to emit a burst of
ultrasound energy. The ultrasonic energy emitted by transducer 130
applies ultrasound therapy 134 within the anatomy 102, including
the occlusion 106. For imaging, the transducer 120 listens for the
returning ultrasound echoes 126 reflected from various tissue
structures of the anatomy 102, such as the occlusion 106. Based on
the IVUS imaging data obtained by the transducer 120, the IVUS
imaging system 160 assembles a two-dimensional image of the vessel
cross-section from a sequence of several hundred of these
ultrasound pulse/echo acquisition sequences occurring during a
single revolution of the transducer 120.
[0046] FIG. 5 is diagrammatic perspective view of the transducer
housing 216 at the distal portion 114 of the catheter 110. FIG. 6
is diagrammatic side view of the transducer housing 216 at the
distal portion 114 of the catheter 110. The ultrasound elements 120
and 130 are fixedly secured to the housing 216 such that rotation
230 of the imaging core 210 and the housing 216 causes rotation 230
of the ultrasound elements 120 and 130. In that regard, the
ultrasound element 120 is structurally arranged and/or otherwise
configured to obtain imaging data while rotating. In ultrasound
element 130 can be is structurally arranged and/or otherwise
configured to apply an ultrasound therapy while rotating. In that
regard, the ultrasound elements 120, 130 can emit and/or receive
ultrasound energy during all or portions of the circumference of
revolution of the drive cable 210. For example, the emitting
ultrasound energy from the ultrasound element 130 during only a
portion of the revolution of the drive cable 210, the ultrasound
therapy can be applied to selected portions of the anatomy 102.
[0047] The ultrasound elements 120 and 130 are mechanically coupled
to the housing 216 using any suitable attachment mechanism, such as
adhesive, welding, soldering, etc. The ultrasound elements 120 and
130 are positioned adjacent to one another along the longitudinal
axis LA. In some instances, the ultrasound elements 120 and 130 can
be referenced as being aligned in series. The ultrasound element
120 can be proximal to the ultrasound element 130, as shown in the
illustrated embodiment, or the ultrasound element 130 can be
proximal to the ultrasound element 120. In some embodiments, the
ultrasound elements 120 are positioned side-by-side along an axis
perpendicular to the longitudinal axis LA. In some embodiments, the
ultrasound elements 120, 130 are disposed on opposite sides of the
housing 216. For example, in the orientation of the housing 216
illustrated in FIG. 6, one of the elements 120, 130 can be disposed
on one side of the housing 216 (e.g., facing up), while the other
of the elements 120, 130 can be disposed on the opposing side of
the housing 216 (e.g., facing down). For example, the ultrasound
elements 120, 130 can be configured to emit ultrasound energy in
opposite directions. In the illustrated embodiment, the ultrasound
elements 120 and 130 are individual ultrasound elements. In other
embodiments, the ultrasound elements 120 and/or 130 can be a one or
two dimensional ultrasound array including two or more ultrasound
transducers.
[0048] The ultrasound elements 120 and 130 include active areas
122, 132, respectively. For example, the active areas 122, 132 are
representative of the ultrasound transducers. The transducers 122,
132 can be suitable shape, including circular as shown in the
illustrated embodiment. Generally, the transducers 122 and/or 132
can be PMUTs, CMUTs, single crystals, PZTs, PZT composites, other
suitable transducer type, and/or combinations thereof. In some
embodiments, both the transducers 122 and 132 are the same
transducer type (e.g., both transducers 122 and 132 are PMUT, CMUT,
single crystal, PZT, PZT composite, etc.). Using the same
transducer type may advantageously simplify manufacturing and/or
implementation for control electronics, electrical wires for
communication, etc. In other embodiments, the transducers 122 and
132 are different transducer types (e.g., transducer 122 is CMUT
and the transducer 132 is PZT, etc.). Using different transducer
types may advantageously allow for transducer types that are
optimized for a given purpose to be used. For example, CMUT may be
advantageously implemented for the imaging transducer 120 to
utilize its higher frequency spectrum. PMUT may be advantageously
implements for the therapeutic transducer 130 to utilize its lower
frequency spectrum.
[0049] The ultrasound element 120 can be structurally arranged
and/or otherwise configured (e.g., material of the transducer,
thickness of one or more components of the transducer, etc.) to
have a relatively higher center frequency than the ultrasound
element 130. Similarly, the ultrasound element 130 can be
structurally arranged and/or otherwise configured (e.g., material
of the transducer, thickness of one or more components of the
transducer, etc.) to have a relatively lower center frequency than
the ultrasound element 120. In some embodiments, the ultrasound
elements 120, 130 can transmit and/or receive at varying
frequencies. For example, the ultrasound elements 120, 130 can be
driven at different operating voltages to change the frequency of
the emitted ultrasound energy. In some embodiments, the ultrasound
element 120 can be tuned to receive ultrasound echoes associated
with different frequencies. In this manner, for example, the
ultrasound elements 120, 130 can be tunable. The ultrasound
elements 120, 130 can be configured to emit and/or receive
ultrasound energy associated with a first frequency range and a
second frequency range, respectively. The first frequency range and
the second frequency range can overlap in some embodiments. In
other embodiments, the first frequency range and the second
frequency range have no overlap or common frequencies.
[0050] The housing 216 can include one or more electronic
components to control the ultrasound elements 120, 130 to emit
ultrasound energy and/or receive ultrasound echoes. For example,
one or more controllers (e.g., ASICs) described herein can disposed
within the housing 216. A single or multiple electrical cables can
be used to connect the elements 120, 130 to the PIM 150, ultrasound
processing system 160, etc. For example, one or more cables can be
used to facilitate electrical communication between the ultrasound
transducer 120 and the PIM 150, computer 160, etc. One or more
cables can be used to facilitate electrical communication between
the ultrasound transducer 120 and the PIM 150, computer 160, etc.
In some embodiments, the same cables are in communication with both
the ultrasound transducers 120, 130, the PIM 150, and the computer
160. The ultrasound transducers 120, 130 can be operated by a user
using the interface 156, the PIM 150, and the computer 160 (e.g.,
physical controls, such as a button, switch, etc., GUI elements on
touchscreen, etc.). For example, the ultrasound transducers 120,
130 can be controlled to operate so that they do not interfere with
one another. For example, ultrasound imaging transducer 120 can be
operated separately from the therapeutic transducer 130 such that
the ultrasound therapy emissions of the transducer 130 do not
interfere with the imaging echoes associated with the transducer
120.
[0051] The housing 216 can be formed of a metal, metal alloy,
polymer, plastic, other suitable material, and/or combinations. The
housing 216 can be generally cylindrically shaped, with cutouts 240
and/or 242. The transducers 120 and 130 are positioned within space
of the housing 216 defined by the cutouts 240 and/or 242. An
acoustic backing material 250 can be disposed within the cutout 242
of the housing 216 to block, dampen, and/or otherwise impede
transmission of sound waves in undesired directions (e.g., opposite
the directions indicated by ultrasound energy 124, 134). An
acoustic matching material can be positioned within the cutout 240
between, surrounding, and/or covering the transducers 120, 130. The
acoustic matching material can be configured to facilitate and/or
other improve transmission of acoustic energy from the ultrasound
transducers 120, 130 (e.g., as indicated by the emitted ultrasound
energy 124, 134 and the reflected ultrasound echoes 126).
[0052] A rotational ultrasound device 110 can be advantageously
utilized with a movement device 180 (e.g., pullback device) to
facilitate intraluminal imaging and/or therapy while the ultrasound
device is pulled back (e.g., longitudinally moved) through the body
lumen at set speeds. Some medical professionals may also prefer the
using the rotational ultrasound device. Rotational ultrasound
devices can also operate at a higher frequency, which can
advantageously allow for higher quality intraluminal images (e.g.,
IVUS images) to be obtained relative to other ultrasound imaging
types. Rotational imaging also advantageously minimizes and/or
eliminates imaging artifacts such as sidelobes, grating lobes, and
poor elevation focus (perpendicular to the imaging plane) relative
to other ultrasound imaging types.
[0053] FIG. 7 provides a flow diagram illustrating a method 700 of
transmitting ultrasound signals. As illustrated, the method 700
includes a number of enumerated steps, but embodiments of the
method 700 may include additional steps before, after, and in
between the enumerated steps. In some embodiments, one or more of
the enumerated steps may be omitted, performed in a different
order, or performed concurrently. The method 700 may be performed
using any of the systems and devices referred to in FIGS. 1-6.
[0054] At step 702, the method 700 may include positioning an
ultrasound device in anatomy of a patient. For example, the
ultrasound device may be a combined intravascular ultrasound (IVUS)
imaging and ultrasound therapy device. The ultrasound device may be
ultrasound device 110 including the ultrasound elements 120, 130.
For example, the ultrasound device can be a rotational ultrasound
device with an imaging ultrasound transducer element and a
therapeutic ultrasound element at the distal portion of a rotating
drive cable. The step 702 can include placing a sheath and the
imaging core/drive cable within the lumen of the anatomy. The drive
cable can be disposed within the sheath of the ultrasound
device.
[0055] At step 704, the method 700 may include transmitting a first
ultrasound signal with a first ultrasound element of the ultrasound
device. The first ultrasound signal can be associated with
ultrasound imaging in some embodiments. Step 704 can be performed
while the drive cable of the ultrasound device and the first
ultrasound element are rotating within the sheath positioned inside
anatomy. In that regard, the method 700 can include connecting the
ultrasound device and/or the drive cable to a movement device, such
as a pullback device, that is configured to rotate and/or
longitudinally translate the ultrasound device. The first
ultrasound signal may be reflected off the anatomy (e.g., tissue,
blood vessel, plaque, etc.) in the form of ultrasound echoes, some
of which may travel back toward the first ultrasound element.
[0056] At step 706, the method 700 may include receiving ultrasound
echoes reflected from the anatomy and associated with the first
ultrasound signal. The ultrasound echoes may be received by the
same ultrasound element that transmitted the first ultrasound
signal. In some embodiments, the data from the ultrasound echoes
may be analyzed by a controller within the ultrasound device (such
as adjacent to the first and/or second ultrasound elements) or
communicated by a cable or other component to a processing device
outside the patient. In some embodiments, the steps 704 and/or 706
can be referenced as obtaining imaging data using the first
ultrasound element.
[0057] At step 708, the method 700 may include generating an image
of the anatomy based the received ultrasound echoes. The image of
the anatomy may be a two- or three-dimensional image of the
anatomy. In some embodiments, the image of the anatomy is displayed
on a display device such as a computer monitor. For example, the
image can be IVUS image of a blood vessel in some embodiments.
[0058] At step 710, the method 700 may include identifying a
treatment plan based on image of the anatomy. In some embodiments,
the image of the anatomy may be analyzed by the system
automatically to detect problems (i.e., calcification, occlusions,
plaques, abnormalities in the anatomy, etc.). The system may be
used to identify a treatment plan based on problems in the image.
In some embodiments, the treatment plan may include a therapeutic
procedure to be performed by the ultrasound device. The method 700
can include evaluating the anatomy based on the obtained image data
(steps 704, 706) and/or the generated imaging (e.g., step 708). For
example, the diameter & calcification of the blood vessel can
be determined using, e.g., virtual histology (VH) and/or other
suitable algorithms. In general, a target site, such as occlusion
106 tends to reflect more ultrasound energy when it has a higher
level of calcification. That is, by measuring the intensity of the
ultrasound signal associated with ultrasound echoes reflected from
the target site, the level of calcification of the target site can
be determined. For example, the method 700 can include determining
the density of an occlusion in the lumen, the age and/or hardness
of the calcium in the vessel plaque, etc. The method 700 and/or
step 710 can include determining one or more ultrasound parameters
for ultrasound therapy. For example, the optimal frequency, pulse
amplitude, pulse length, and/or other suitable parameters for
ultrasound cavitation/vessel preparation with the second ultrasound
element can be determined in an automated process by the computer
or by a medical professional. After the ultrasound processing
system 160 determines the set of ultrasound parameters, the
ultrasound processing system 160 can transmit an electrical signal
representative of the parameters to the ultrasound transducer 130
such that the ultrasound transducer 130 operates based on the
parameters.
[0059] Detecting and characterizing plaque using IVUS with VH are
described in, for example, U.S. Pat. No. 6,200,268 entitled
"VASCULAR PLAQUE CHARACTERIZATION" issued Mar. 13, 2001 with D.
Geoffrey Vince, Barry D. Kuban and Anuja Nair as inventors, U.S.
Pat. No. 6,381,350 entitled "INTRAVASCULAR ULTRASONIC ANALYSIS
USING ACTIVE CONTOUR METHOD AND SYSTEM" issued Apr. 30, 2002 with
Jon D. Klingensmith, D. Geoffrey Vince and Raj Shekhar as
inventors, U.S. Pat. No. 7,074,188 entitled "SYSTEM AND METHOD OF
CHARACTERIZING VASCULAR TISSUE" issued Jul. 11, 2006 with Anuja
Nair, D. Geoffrey Vince, Jon D. Klingensmith and Barry D. Kuban as
inventors, U.S. Pat. No. 7,175,597 entitled "NON-INVASIVE TISSUE
CHARACTERIZATION SYSTEM AND METHOD" issued Feb. 13, 2007 with D.
Geoffrey Vince, Anuja Nair and Jon D. Klingensmith as inventors,
U.S. Pat. No. 7,215,802 entitled "SYSTEM AND METHOD FOR VASCULAR
BORDER DETECTION" issued May 8, 2007 with Jon D. Klingensmith,
Anuja Nair, Barry D. Kuban and D. Geoffrey Vince as inventors, U.S.
Pat. No. 7,359,554 entitled "SYSTEM AND METHOD FOR IDENTIFYING A
VASCULAR BORDER" issued Apr. 15, 2008 with Jon D. Klingensmith, D.
Geoffrey Vince, Anuja Nair and Barry D. Kuban as inventors and U.S.
Pat. No. 7,463,759 entitled "SYSTEM AND METHOD FOR VASCULAR BORDER
DETECTION" issued Dec. 9, 2008 with Jon D. Klingensmith, Anuja
Nair, Barry D. Kuban and D. Geoffrey Vince, as inventors, the
teachings of which are hereby incorporated by reference herein in
their entireties.
[0060] At step 712, the method 700 may include transmitting a
second ultrasound signal with a second ultrasound element of the
ultrasound device. In that regard, the second ultrasound signal can
be associated with therapy of the anatomy in which the ultrasound
device is positioned. Step 712 can be performed while the drive
cable of the ultrasound device and the second ultrasound element
are rotating within the sheath positioned inside anatomy. Between
steps 704 and 712, the method 700 and associates systems and
devices switch from imaging mode to a therapy mode to facilitate
treatment of the diseased area, cavitation, thermal or
ultrasound/vessel preparation, with the parameters determined in
step 710. The second ultrasound element may be adjacent to the
first ultrasound element. In some embodiments, the second
ultrasound element is configured to transmit ultrasound signals but
not receive ultrasound signals. The second ultrasound signal may
have a frequency lower than that of the first ultrasound signal. In
some implementations, the second ultrasound signal is transmitted
to perform a therapeutic procedure such as creating micro fractures
in the anatomy and/or treating the anatomy in preparation for
delivery of a drug.
[0061] At step 714, the method 700 may optionally include imaging
the anatomy with the firs ultrasound element to determine the
effectiveness of the treatment plan. In some embodiments, the first
ultrasound element may be used to transmit another ultrasound
signal and receive the reflected ultrasound echoes to determine if
the desired effect has been achieved. In some embodiments, the
ultrasound device may be used to image anatomy after treatment to
identify further problem areas or conditions (such as identifying
emboli in the anatomy after a procedure). Thus, the method 700
includes switching from treatment mode to IVUS mode to evaluate the
effectiveness of ultrasound therapy. The steps 710, 712, and 714
can be repeated as needed to utilize ultrasound for imaging and
ultrasound therapy. The method 700 can be completed while the
ultrasound device remaining positioned within the anatomy.
Advantageously, diagnostic imaging and therapeutic steps can be
performed without removing the ultrasound device from the anatomy
and inserting other devices.
[0062] The method 700 can include treating the diseased area with
additional methods if necessary. For example, diseased area of a
blood vessel can be dilated using balloon catheter, a correctly
sized stent can be positioned inside the blood vessel, and/or drugs
can be delivery to the diseased area of the blood vessel. In some
embodiments, the additional treatment can be delivered using a
therapeutic component of the ultrasound device positioned within
the anatomy. In other embodiments, the ultrasound device can be
removed and another device can be positioned within anatomy to
treat the diseased area. The method 700 can include utilizing the
first ultrasound element of the ultrasound device to obtain imaging
data of the anatomy, after the additional treatment is complete, to
evaluate the effectiveness of the additional treatment.
[0063] The systems, devices, and methods of the present disclosure
can include features described in U.S. Provisional application Ser.
No. ______ (Atty. Dkt. No. 2017PF02285/44755.1808PV01), filed on an
even date herewith, U.S. Provisional application Ser. No. ______
(Atty. Dkt. No. 2017PF02287/44755.1809PV01), filed on an even date
herewith, U.S. Provisional application Ser. No. ______ (Atty. Dkt.
No. 2017PF02288/44755.1810PV01), filed on an even date herewith,
and/or U.S. Provisional application Ser. No. ______ (Atty. Dkt. No.
2017PF02289/44755.1811PV01), filed on an even date herewith, the
entireties of which are hereby incorporated by reference
herein.
[0064] Persons skilled in the art will recognize that the
apparatus, systems, and methods described above can be modified in
various ways. Accordingly, persons of ordinary skill in the art
will appreciate that the embodiments encompassed by the present
disclosure are not limited to the particular exemplary embodiments
described above. In that regard, although illustrative embodiments
have been shown and described, a wide range of modification,
change, and substitution is contemplated in the foregoing
disclosure. It is understood that such variations may be made to
the foregoing without departing from the scope of the present
disclosure. Accordingly, it is appropriate that the appended claims
be construed broadly and in a manner consistent with the present
disclosure.
* * * * *